Opinion
VIEWPOINT
Andrew J. Schoenfeld, MD, MSc Robert Wood Johnson Clinical Scholars Program, University of Michigan, Ann Arbor. Mitchel B. Harris, MD Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, Massachusetts. Matthew Davis, MD, MAPP Robert Wood Johnson Clinical Scholars Program, University of Michigan, Ann Arbor.
Corresponding Author: Andrew J. Schoenfeld, MD, Robert Wood Johnson Clinical Scholars Program, University of Michigan, 2800 Plymouth Rd, Bldg 10, Room G016, Ann Arbor, MI 48109 (ajschoen @neomed.edu).
Clinical Uncertainty at the Intersection of Advancing Technology, Evidence-Based Medicine, and Health Care Policy Physicians are regularly challenged to make treatment recommendations for patients whose diagnosis and prognosis are uncertain and for whom the highest-quality evidence is inconclusive. Consequently, physicians are generally accustomed to functioning in the fog of uncertainty. Until now, the dynamics of clinical decisions in the midst of uncertainty have been left to physicians to manage in partnership with their patients. This is about to change, however, under stipulations of the Affordable Care Act (ACA). Even as uncertainty persists, the ACA will exert pressure to measure quality in uniform ways that make winners and losers based on physicians’ different practice approaches. Nonetheless, to say that some physicians will be winners does not imply that patients will also win, particularly if newly established quality measures favor practice approaches that are ultimately proven inferior, with respect to patients’ outcomes. The importance of addressing clinical uncertainty in the ACA era and the potentially adverse impact that regulatory approaches may have on patient care is illustrated by the controversy regarding cervical spine evaluation in the obtunded trauma patient, a clinical scenario that occurs more than 1 million times each year. During the last 2 decades, the use of multidetector computed tomography (MDCT) as the primary means of diagnosing cervical spine trauma has become standard of care. In obtunded trauma patients, many physicians maintain that normal MDCT is sufficient to clear the cervical spine.1,2 Others advocate that additional magnetic resonance imaging (MRI) is necessary to definitively exclude occult trauma. 3,4 There is published evidence available to support both contentions, although the level of quality in peer-reviewed studies is less than adequate.1-4 While acknowledging that MRI can identify injuries missed by MDCT, many physicians argue that such findings are often clinically insignificant and unlikely to alter treatment plans.1-3 In their view, the use of MRI needlessly increases health care costs ($1000$4000 per noncontrast MRI) and places patients at risk of unnecessary interventions, whether surgical or nonoperative. Those who support the use of adjunct MRI counter that neither the status of the spinal cord nor the integrity of the spinal ligamentous structures can be comprehensively assessed without the use of magnetic resonance technology.3,4 These physicians believe that the costs of treating a single case of iatrogenic spinal cord injury incurred because of a false-
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normal computed tomography far outweigh charges related to the performance of adjunct MRI. The current literature fails to support the use of either imaging protocol as the conclusive diagnostic test for occult spinal trauma. To our knowledge, no studies to date have used blind comparisons with a reference standard, nor have any used a referent irrespective of the diagnostic test result. The acuity and intensity of this debate are accentuated by looming requirements of the ACA.5 The ACA’s provisions for trauma care include a mandate for the National Quality Forum to establish evidence-based standards of trauma practice.5 In addition, calls for valuebased insurance within the ACA also promote the use of evidence-based medicine as a means to provide highquality health care while curtailing costs. Given the present state of the literature, regulatory approaches may preferentially move toward MDCT alone as the accepted pathway for cervical spine clearance in the obtunded trauma patient.1,2 If this becomes accepted policy, health care systems and professionals could be penalized if they continue to use MRI as an adjunct to clear the cervical spine following normal MDCT. Such blanket approaches might also harm patients, given that a certain number of individuals with normal MDCT may still have undiagnosed cervical spine injuries that could result in quadriplegia if left untreated.3,4 Owing to the quality of the present literature, the actual false-normal rate of computed tomography imaging, particularly with respect to clinically significant occult injuries, remains unknown.1-4 At the dimly lit crossroads of advancing medical technology, evidence-based medicine, and health care policy, the medical community would benefit patients and support physicians by adopting a research agenda that can realistically provide highquality evidence to inform policy choices. A multicenter, prospective investigation designed to accurately assess the specificity and negative predictive value of MDCT would undoubtedly assist in resolving this controversy; yet, to our knowledge, no such study is under way. Consequently, a multipronged approach that balances the needs of patients and the requirements of regulatory guidelines is necessary. We favor a plan (Figure) that culminates in a multicenter study capable of defining an optimal clearance protocol. En route to the definite study, it would be appropriate in the first phase to acknowledge that current literature cannot establish a superior protocol for evaluation of JAMA Surgery December 2014 Volume 149, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a J H Quillen College User on 06/08/2015
1221
Opinion Viewpoint
Figure. Algorithms for Establishing Quality Measures General case: Algorithm for establishing quality measures in context of evidence uncertainty
Specific case: Algorithm for establishing quality measures for spinal clearance in obtunded patients
Phase 1 Objective appraisal of the current state of the literature; identify equivalent approaches
Phase 1 Current literature cannot support MDCT alone in comparison with MDCT and MRI as a superior clearance protocol
Phase 2 Rigorous hierarchical analysis of national registry data; begin multicenter prospective study
Phase 2 Use national registry data to inform regulatory initiatives and research design for multicenter study
Phase 3 From prospective study, identify best approach and specify relevant quality measure(s)
Phase 3 Use multicenter prospective study of spinal clearance to decide optimal protocol; set quality measure(s)
Parallel algorithms for establishing quality measures in general and in the specific instance of cervical spine clearance. MDCT indicates multidetector computed tomography and MRI, magnetic resonance imaging.
the cervical spine. In the second phase, national registry data such as the Trauma Quality Improvement Program would be used in hierarchical analyses (that permit consideration of patientARTICLE INFORMATION
REFERENCES
Published Online: November 5, 2014. doi:10.1001/jamasurg.2014.382.
1. Como JJ, Leukhardt WH, Anderson JS, Wilczewski PA, Samia H, Claridge JA. Computed tomography alone may clear the cervical spine in obtunded blunt trauma patients: a prospective evaluation of a revised protocol. J Trauma. 2011;70(2):345-349, discussion 349-351.
Conflict of Interest Disclosures: Dr Schoenfeld is an employee of the US federal government and a Robert Wood Johnson Foundation Clinical Scholar. No other disclosures were reported. Disclaimer: The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or reflecting the views of the US government. Any opinions expressed herein do not necessarily reflect the opinions of the Robert Wood Johnson Foundation or the Department of Veterans Affairs.
1222
level, physician-level, and institution-level factors) to broaden the base of clinical evidence while awaiting results of the multicenter trial. In the third phase, the definitive study must enroll a large number of obtunded blunt trauma patients from multiple clinical sites and require that all individuals receive both MDCT and MRI. Magnetic resonance imaging would serve as the reference standard to which independent, blind comparisons of MDCT results would be made. Clinically significant MRI findings would be determined a priori as those that alter patient management, including continued use of a cervical orthosis or surgical intervention. Although well-intentioned, regulatory provisions of the ACA intended to draw on evidence—but currently find evidence indeterminate—have the potential to adversely impact patient care in disciplines as diverse as pediatrics and trauma surgery. The 3-phase plan outlined above can yield progressively higher levels of evidence for diagnostic tests and treatment protocols, thereby informing policy decisions to the greatest extent possible at the given time. With specific regard to cervical spine evaluation, our agenda may also lead to conclusive determination of the ideal diagnostic modality for occult cervical trauma. We fear that failure to act on the part of physicians from all disciplines (essentially, acceptance of the status quo) would represent a missed opportunity that may impair the clinical practice of medicine and unnecessarily heighten the risk of unintended harm to patients.
2. Raza M, Elkhodair S, Zaheer A, Yousaf S. Safe cervical spine clearance in adult obtunded blunt trauma patients on the basis of a normal multidetector CT scan: a meta-analysis and cohort study. Injury. 2013;44(11):1589-1595. 3. Schoenfeld AJ, Bono CM, McGuire KJ, Warholic N, Harris MB. Computed tomography alone versus computed tomography and magnetic resonance
imaging in the identification of occult injuries to the cervical spine: a meta-analysis. J Trauma. 2010;68(1):109-113, discussion 113-114. 4. Fisher BM, Cowles S, Matulich JR, Evanson BG, Vega D, Dissanaike S. Is magnetic resonance imaging in addition to a computed tomographic scan necessary to identify clinically significant cervical spine injuries in obtunded blunt trauma patients? Am J Surg. 2013;206(6):987-993, discussion 993-994. 5. Office of the Legal Counsel for the US House of Representatives. Compilation of Patient Protection and Affordable Care Act. Washington, DC: Office of the Legal Counsel for the US House of Representatives; 2010.
JAMA Surgery December 2014 Volume 149, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a J H Quillen College User on 06/08/2015
jamasurgery.com
VIEWPOINT
Andrew J. Schoenfeld, MD, MSc Robert Wood Johnson Clinical Scholars Program, University of Michigan, Ann Arbor. Mitchel B. Harris, MD Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, Massachusetts. Matthew Davis, MD, MAPP Robert Wood Johnson Clinical Scholars Program, University of Michigan, Ann Arbor.
Corresponding Author: Andrew J. Schoenfeld, MD, Robert Wood Johnson Clinical Scholars Program, University of Michigan, 2800 Plymouth Rd, Bldg 10, Room G016, Ann Arbor, MI 48109 (ajschoen @neomed.edu).
Clinical Uncertainty at the Intersection of Advancing Technology, Evidence-Based Medicine, and Health Care Policy Physicians are regularly challenged to make treatment recommendations for patients whose diagnosis and prognosis are uncertain and for whom the highest-quality evidence is inconclusive. Consequently, physicians are generally accustomed to functioning in the fog of uncertainty. Until now, the dynamics of clinical decisions in the midst of uncertainty have been left to physicians to manage in partnership with their patients. This is about to change, however, under stipulations of the Affordable Care Act (ACA). Even as uncertainty persists, the ACA will exert pressure to measure quality in uniform ways that make winners and losers based on physicians’ different practice approaches. Nonetheless, to say that some physicians will be winners does not imply that patients will also win, particularly if newly established quality measures favor practice approaches that are ultimately proven inferior, with respect to patients’ outcomes. The importance of addressing clinical uncertainty in the ACA era and the potentially adverse impact that regulatory approaches may have on patient care is illustrated by the controversy regarding cervical spine evaluation in the obtunded trauma patient, a clinical scenario that occurs more than 1 million times each year. During the last 2 decades, the use of multidetector computed tomography (MDCT) as the primary means of diagnosing cervical spine trauma has become standard of care. In obtunded trauma patients, many physicians maintain that normal MDCT is sufficient to clear the cervical spine.1,2 Others advocate that additional magnetic resonance imaging (MRI) is necessary to definitively exclude occult trauma. 3,4 There is published evidence available to support both contentions, although the level of quality in peer-reviewed studies is less than adequate.1-4 While acknowledging that MRI can identify injuries missed by MDCT, many physicians argue that such findings are often clinically insignificant and unlikely to alter treatment plans.1-3 In their view, the use of MRI needlessly increases health care costs ($1000$4000 per noncontrast MRI) and places patients at risk of unnecessary interventions, whether surgical or nonoperative. Those who support the use of adjunct MRI counter that neither the status of the spinal cord nor the integrity of the spinal ligamentous structures can be comprehensively assessed without the use of magnetic resonance technology.3,4 These physicians believe that the costs of treating a single case of iatrogenic spinal cord injury incurred because of a false-
jamasurgery.com
normal computed tomography far outweigh charges related to the performance of adjunct MRI. The current literature fails to support the use of either imaging protocol as the conclusive diagnostic test for occult spinal trauma. To our knowledge, no studies to date have used blind comparisons with a reference standard, nor have any used a referent irrespective of the diagnostic test result. The acuity and intensity of this debate are accentuated by looming requirements of the ACA.5 The ACA’s provisions for trauma care include a mandate for the National Quality Forum to establish evidence-based standards of trauma practice.5 In addition, calls for valuebased insurance within the ACA also promote the use of evidence-based medicine as a means to provide highquality health care while curtailing costs. Given the present state of the literature, regulatory approaches may preferentially move toward MDCT alone as the accepted pathway for cervical spine clearance in the obtunded trauma patient.1,2 If this becomes accepted policy, health care systems and professionals could be penalized if they continue to use MRI as an adjunct to clear the cervical spine following normal MDCT. Such blanket approaches might also harm patients, given that a certain number of individuals with normal MDCT may still have undiagnosed cervical spine injuries that could result in quadriplegia if left untreated.3,4 Owing to the quality of the present literature, the actual false-normal rate of computed tomography imaging, particularly with respect to clinically significant occult injuries, remains unknown.1-4 At the dimly lit crossroads of advancing medical technology, evidence-based medicine, and health care policy, the medical community would benefit patients and support physicians by adopting a research agenda that can realistically provide highquality evidence to inform policy choices. A multicenter, prospective investigation designed to accurately assess the specificity and negative predictive value of MDCT would undoubtedly assist in resolving this controversy; yet, to our knowledge, no such study is under way. Consequently, a multipronged approach that balances the needs of patients and the requirements of regulatory guidelines is necessary. We favor a plan (Figure) that culminates in a multicenter study capable of defining an optimal clearance protocol. En route to the definite study, it would be appropriate in the first phase to acknowledge that current literature cannot establish a superior protocol for evaluation of JAMA Surgery December 2014 Volume 149, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a J H Quillen College User on 06/08/2015
1221
Opinion Viewpoint
Figure. Algorithms for Establishing Quality Measures General case: Algorithm for establishing quality measures in context of evidence uncertainty
Specific case: Algorithm for establishing quality measures for spinal clearance in obtunded patients
Phase 1 Objective appraisal of the current state of the literature; identify equivalent approaches
Phase 1 Current literature cannot support MDCT alone in comparison with MDCT and MRI as a superior clearance protocol
Phase 2 Rigorous hierarchical analysis of national registry data; begin multicenter prospective study
Phase 2 Use national registry data to inform regulatory initiatives and research design for multicenter study
Phase 3 From prospective study, identify best approach and specify relevant quality measure(s)
Phase 3 Use multicenter prospective study of spinal clearance to decide optimal protocol; set quality measure(s)
Parallel algorithms for establishing quality measures in general and in the specific instance of cervical spine clearance. MDCT indicates multidetector computed tomography and MRI, magnetic resonance imaging.
the cervical spine. In the second phase, national registry data such as the Trauma Quality Improvement Program would be used in hierarchical analyses (that permit consideration of patientARTICLE INFORMATION
REFERENCES
Published Online: November 5, 2014. doi:10.1001/jamasurg.2014.382.
1. Como JJ, Leukhardt WH, Anderson JS, Wilczewski PA, Samia H, Claridge JA. Computed tomography alone may clear the cervical spine in obtunded blunt trauma patients: a prospective evaluation of a revised protocol. J Trauma. 2011;70(2):345-349, discussion 349-351.
Conflict of Interest Disclosures: Dr Schoenfeld is an employee of the US federal government and a Robert Wood Johnson Foundation Clinical Scholar. No other disclosures were reported. Disclaimer: The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or reflecting the views of the US government. Any opinions expressed herein do not necessarily reflect the opinions of the Robert Wood Johnson Foundation or the Department of Veterans Affairs.
1222
level, physician-level, and institution-level factors) to broaden the base of clinical evidence while awaiting results of the multicenter trial. In the third phase, the definitive study must enroll a large number of obtunded blunt trauma patients from multiple clinical sites and require that all individuals receive both MDCT and MRI. Magnetic resonance imaging would serve as the reference standard to which independent, blind comparisons of MDCT results would be made. Clinically significant MRI findings would be determined a priori as those that alter patient management, including continued use of a cervical orthosis or surgical intervention. Although well-intentioned, regulatory provisions of the ACA intended to draw on evidence—but currently find evidence indeterminate—have the potential to adversely impact patient care in disciplines as diverse as pediatrics and trauma surgery. The 3-phase plan outlined above can yield progressively higher levels of evidence for diagnostic tests and treatment protocols, thereby informing policy decisions to the greatest extent possible at the given time. With specific regard to cervical spine evaluation, our agenda may also lead to conclusive determination of the ideal diagnostic modality for occult cervical trauma. We fear that failure to act on the part of physicians from all disciplines (essentially, acceptance of the status quo) would represent a missed opportunity that may impair the clinical practice of medicine and unnecessarily heighten the risk of unintended harm to patients.
2. Raza M, Elkhodair S, Zaheer A, Yousaf S. Safe cervical spine clearance in adult obtunded blunt trauma patients on the basis of a normal multidetector CT scan: a meta-analysis and cohort study. Injury. 2013;44(11):1589-1595. 3. Schoenfeld AJ, Bono CM, McGuire KJ, Warholic N, Harris MB. Computed tomography alone versus computed tomography and magnetic resonance
imaging in the identification of occult injuries to the cervical spine: a meta-analysis. J Trauma. 2010;68(1):109-113, discussion 113-114. 4. Fisher BM, Cowles S, Matulich JR, Evanson BG, Vega D, Dissanaike S. Is magnetic resonance imaging in addition to a computed tomographic scan necessary to identify clinically significant cervical spine injuries in obtunded blunt trauma patients? Am J Surg. 2013;206(6):987-993, discussion 993-994. 5. Office of the Legal Counsel for the US House of Representatives. Compilation of Patient Protection and Affordable Care Act. Washington, DC: Office of the Legal Counsel for the US House of Representatives; 2010.
JAMA Surgery December 2014 Volume 149, Number 12
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archsurg.jamanetwork.com/ by a J H Quillen College User on 06/08/2015
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